NL-OMON48751招募中不适用
Combining drug-eluting bead transarterial chemoembolisation and radioembolization for treatment of colorectal liver metastases: DEBIR90Y study - DEBIR90Y
niversitair Medisch Centrum Utrecht0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Written informed consent.
- •2. >=18 years old with confirmed unresectable liver metastases from CRC
- •3. The primary tumor should be clinically stable.
- •4. Bilobar (to avoid bias in toxicity analysis), unresectable liver dominant
- •mCRC (i.e. up to 2 lesions limited to one extra-hepatic organ with a maximum
- •size of 1 cm and 2 cm for lymph nodes), with disease progression after first
- •line systemic treatment.
- •5. Eligible to receive second-line standard-of-care chemotherapy with an
- •irinotecan-based chemotherapy regimen.
- •6. Measurable (target) liver lesions on contrast-enhanced CT, according to
- •RECIST 1.1.
- •7. Contrast-enhanced CT and FDG-PET-CT maximum 4 weeks prior to enrolment.
- •8. Tumor replacement >= 5% and <= 50% of total liver volume.
- •9. Started the last cycle of the first line chemotherapy (without irinotecan)
- •at least 28 days prior to the initiation of second line chemotherapy under the
- •10. Eastern Cooperative Oncology Group performance status 0-1.
- •11. Life expectancy of >= 12 weeks.
- •12. Hematologic function: WBC >= 3.0 x 10^9/L, platelets >= 100 x 10^9/L,
- •absolute neutrophil count ; 1.5 x 10^9/L, Hemoglobin; 5 mmol/L.
- •13. Adequate organ function as measured by:
- •o GFR >= 35 ml/min.
- •o Serum transaminases (AST; ALT) <= 5 x ULN.
- •o Total bilirubin <= 1 x ULN
- •o Albumin > 3 g/dL.
排除标准
- •1. History of hepatic encephalopathy.
- •2. Contraindications to angiography.
- •3. Known severe allergy or intolerance to contrast agents, that cannot be
- •managed medically.
- •4. Pulmonary insufficiency or clinically evident chronic obstructive pulmonary
- •5. Cirrhosis or portal hypertension.
- •6. Prior liver-directed therapy (i.e. EBRT, chemoembolization,
- •radioembolization, hepatic segmentectomies, radiofrequency ablation spanning >2
- •7. Treatment with VEGF inhibitors within 28 days prior to receiving 90Y glass
- •microspheres.
- •8. Prior intervention for, or compromise of, the Ampulla of Vater.
- •9. Presence of clinically evident ascites (trace ascites on imaging is
- •acceptable), or Child-Pugh score B/C.
- •10. Toxicities due to prior cancer therapy that have not resolved before the
- •initiation of study treatment, if the investigator determines that the
- •continuing complication will compromise the safe treatment of the patient.
- •11. Significant life-threatening extra-hepatic disease, including patients who
- •have unresolved diarrhea or serious unresolved infections (e.g. patients who
- •are known to be HIV positive or have acute HBV or HCV).
- •12. Contraindications to the planned second line standard-of-care chemotherapy
- •13. Pregnancy and/or breastfeeding.
- •14. Patients suffering from psychic disorders that make a comprehensive
- •judgment impossible, such as psychosis, hallucinations and/or depression.
- •15. Patients who are declared incapacitated.
- •16. Participation in a clinical trial with an investigational therapy within 30
- •days prior to enrolment.
- •17. Any co-morbid disease or condition that would place the patient at undue
- •18. Contraindications to TACE (e.g. porto-systemic shunt, portal vein
- •thrombosis, hepatofugal blood flow, severe atherosclerosis precluding arterial
- •19. Contraindications to irinotecan (concomitant use with St John*s wort).
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